Device for emergency treatment of cardiac arrest

ABSTRACT

A device for providing resuscitation or suspended state through redistribution of cardiac output to increase supply to the brain and heart for a patient. The device comprises an electrically controllable redistribution component in the form of a catheter, attachable to the patient and configured to interact with the patient to provide redistribution of the cardiac output to increase supply to the brain and heart, the redistribution component following a predefined reaction pattern based on an electrical signal, and computer configured to: receive a patient data which identifies physiological and/or anatomical characteristics of the patient; and provide the electrical signal for the redistribution component based on the patient data or a standard response. The device also comprises means for detection of blood vessels and motorized means for introduction of the catheter into an artery.

FIELD OF THE INVENTION

The invention relates to devices and methods for providing resuscitationor suspended state in cardiac arrest, e.g. to increase return ofspontaneous circulation (ROSC) or to expand the time window ofintervention to enable new opportunities for diagnostics and treatmentsfor patients in cardiac arrest.

BACKGROUND OF THE INVENTION

Cardiovascular disease contributes 30.9% of global mortality. Currentlyonly 1 out of 10 survive a cardiac arrest to hospital discharge. It isresponsible for higher mortality rates than any other disease inindustrialized countries, and three-quarters of non-infectious mortalityin developing countries. In the US there are around 350.000 cardiacarrests outside of hospitals; and at least as many inside hospitals. Thepotential for improvement is massive. In 2010, the cost of medical carefor heart disease in the US was $273 billion and the loss inproductivity was $172 billion.

By the early 1970s, CPR (Cardiopulmonary Resuscitation), defibrillation,and prehospital care were all in place. The introduction of automateddefibrillation units (AED) expanded the possibility for prehospitaltreatment of cardiac arrest, and the first AED was successfully put touse by paramedics in Brighton in 1980. In spite of this, our currentbest practice only has the ability to achieve resuscitation, return ofspontaneous circulation (ROSC), for around 25-30% of patients both inpre-hospital and in-hospital settings.

There is a change in the characteristics of the population sufferingcardiac arrest. Ten years ago, broad population studies showed thataround 70% of people suffering cardiac arrest had initial shockablerhythms (ventricular fibrillation or ventricular tachycardia) as thefirst documented electrocardiographic rhythm. Today, multiple largepopulation studies note that only 20% to 30% of those suffering acardiac arrest have a shockable rhythm as their initial rhythm.

The defibrillator is far from effective for everyone, even whenstratifying for presenting rhythm. Roughly stated electricity cannotopen an occluded coronary artery. There is rarely enough time todiagnose and treat the underlying cause of the cardiac arrest, and evendefibrillation depends on optimizing hemodynamic variables beforehand.From other patient settings we know of and perform time-consumingtreatments that could save the patients life but cannot currently beperformed within the time constraints of a cardiac arrest.

This change in initial arrhythmia also has wide implications. We can tryto defibrillate a shockable rhythm, but we have no truly effectivetreatments otherwise.

CPR and Defibrillation have been basically unchanged since theirimplementation. CPR cannot generate sufficient cerebral blood flow topreserve normal cerebral viability until cardiac function is restored.This explains why cardiac arrest has such high neurological morbidityand mortality. Therefore, we need new methods to improve cerebral bloodflow and subsequent neurological outcome from cardiac arrest, especiallyif we want to do more efforts than defibrillation. Even if onlydefibrillation is performed, new methods to improve coronary blood flowcan improve the likelihood of success from defibrillation.

As an example, coronary artery disease represents the most common causeof out-of-hospital cardiac arrest, but the treatment, percutaneouscoronary intervention (PCI), cannot to be performed within the timelimits of current CPR. Alternatively, even treatments of fibrinolyticsand CABG (coronary artery bypass graft surgery), takes too long time toperform in a cardiac arrest.

Cooling (therapeutic hypothermia) has only proved useful in the patientsthat achieve a return of heartbeat, so-called ROSC (return ofspontaneous circulation), and do not alter the proportion of those whoachieve ROSC or not. Cooling slows down the cellular requirement,lowering the need to match the lowered supply—e.g. cerebral metabolicdemands lower by about 8% per degree Celsius drop in temperature—but itusually takes hours to reach the desired temperature and is thereforenot an effective way to bridge the patient in cardiac arrest todefinitive treatment. By then, the patient is already irreversibly andtotally neurologically damaged.

Late therapy like cardiopulmonary bypass or ECMO (extra corporalmembrane oxygenation) devices, no matter how good, is never effectiveonce the ischemic capability of the heart and brain is exceeded.Nevertheless, recovery may be improved by these devices, whichunfortunately cannot be initiated fast enough in cardiac arrest toreplace the need for an intermediate suspended state device.

Continued cardiac arrest will result in metabolic acidosis. Here e.g.sodium bicarbonate can maintain blood pH and plasmapheresis can clearthe build-up of toxins.

OBJECTS OF THE INVENTION

It is an object of embodiments of the invention to provide a device or asystem that enables blood redistribution in a patient suffering fromcardiac arrest, so as to render heart massage (chest compression) moreeffective in maintaining the vital perfusion of the CNS. It is a furtherobject of embodiments of the invention to provide a method for providingresuscitation or suspended state in a cardiac arrest patient. It is alsoan object of embodiments of the invention to provide a device and amethod by which ease-of-use and a built-in safety can withhold thepotentially damaging effect of a cardiac output redistribution methodand thereby enable methods for providing suspended state or immediateresuscitation. It is a further object to provide a device and a methodby which a patient can be placed in suspended state in both thenear-community and hospital settings, in hands of users with minimaltraining, to thereby allow not only in-hospital specialists but alsoprehospital health care professionals and others to carry out suchprocedures to thereby achieve a marked expansion of the time window toreverse a cardiac arrest, or improve the likelihood of success fromimmediate defibrillation.

Particularly, it is an object of embodiments of the invention to enablethe delivery of diagnostics and treatments that cannot currently bedelivered to the patient in cardiac arrest, where almost universallyonly defibrillation and drug administration can be achieved within thecurrent window of intervention of around 10-30 minutes.

SUMMARY OF THE INVENTION

It has been found by the present inventor that a main problem duringcardiopulmonary resuscitation (CPR) of cardiac arrest patients is thefact that non-vital organs and tissues are perfused and supplied withoxygen at an—under these circumstances—unnecessary high level and thatthis happens at the expense of the CNS, in particular the brain, and theheart, which in contrast to these non-vital organs and tissues arehighly sensitive to low oxygenation. Further it has been found by theinventor that if this imbalance during CPR could be changed to favourthe perfusion of the CNS and the heart, then the chances of survival ofthese patients would be greatly enhanced.

However, it is normally necessary to perform a surgical intervention inorder to establish preferential perfusion of the brain and heart in apatient and this surgical intervention requires the skills of a surgeon.On the other hand, staff of rescue teams is normally not surgeons so itis hence advantageous to be able to provide a device or system, whichvia a very simple intervention—which does not require surgicalskills—can bring about the advantageous preferential perfusion of brainand heart.

The present inventor has hence realized a novel technological applianceand new methods. Unlike cooling (also referred to as ‘suspendedanimation’), were the metabolism in the cells is slowed downconsiderably, which cannot be initiated fast enough if the cardiacarrest has already occurred, we wish to introduce a new term of‘suspended state’, where the neurological damage process itself is putto a halt, by controlled redistribution of the cardiac output from chestcompressions to the brain and heart—to create an increasing metabolicdebt to the tissues that can tolerate this state, thus still keepingevery single cell in the body viable. The use of a supraceliac aorticocclusion can increase the coronary and cerebral perfusion pressure withabout a 100%, thus reaching viable levels again. We can extrapolate thisfrom the use of cross clamps in surgical correction of aortic aneurysms,from the use of simple surgical balloon catheters in e.g. aorticaneurysm graft expansion and in the care of pelvic and truncal traumas,and that the remaining organs can tolerate this intervention for sometime.

The use of vasodilator drugs can have a substantial impact on loweringthe restriction on perfusion delivered to the brain and heart. For thefirst time we want to propose the use of a cardiac arrest aorticocclusion balloon therapy being used together with the addition ofhigh-potency vasodilators, hereunder sodium nitroprusside or high-dosenitro-glycerine, to create a high-flow state to the brain and heart withlow microcirculatory resistance, while at the same mitigating thesystemic vascular collapse caused by the vasodilator through the use ofthe aortic occlusion balloon.

Using this one or several abovementioned in a new bridge therapy couldcarry patients in cardiac arrest directly to definitive treatmentmethods, or to an intermediate intervention such as hypothermia or ECMOand subsequently to definitive treatment methods. However, these devicesand methods will remain theoretical curiosities, if we do not alsoinvent ways of putting them in the hands of the doctors, paramedics andnurses, that deliver the first-aid for patients in cardiac arrest, andnot only in the hands of our specialist physicians in the receivinghospital departments. Alternatively the proposed methods can be used toincrease the immediate resuscitation chances from e.g. defibrillation.

The population who suffers from cardiac arrest very often suffers fromcomorbid aortic atherosclerosis making the aorta fragile, brittle andporcelain-like. This makes it necessary to invent intelligent safe waysin which the redistribution can be carried out while protecting theanatomy of the patient to the maximum possible extent. The use ofexternal abdominal aortic binding or compression as an alternative to anendovascular technique is therefore not without substantial risk and canlead to e.g. plaque rupture, dissection, wall rupture, or thromboembolicincidences.

On the other hand, leading a balloon catheter blindly without carefulcontrol of where and when the balloon exercises its pressure can lead todamage on the patient's anatomy, especially in the stressful situationof a cardiac arrest. If only verified by human estimation, the ballooncatheter could inadvertently, how rare these incidences might occur, endin e.g. an arterial branch of the aorta, in a venous vessel side of thevascular system, in a dissection between layers of the aortic wall or ina tissue compartment outside of the vascular system.

To improve the existing methods for redistribution, and to enable saferedistribution for non-medical practitioners or semi-skilledpractitioners, e.g. for rescue teams etc. the present invention henceprovides in a first aspect a device or system for providingresuscitation or suspended state through redistribution of cardiacoutput to increase supply to the brain and heart for a patient, thedevice comprising

-   -   an electrically or manually controllable redistribution        component in the form of a catheter attachable to the patient        and being configured to interact with the patient to provide        redistribution of the cardiac output to increase supply to the        brain and heart, the redistribution component following a        predefined reaction pattern based on an electrical signal,    -   computer means configured to 1) receive a patient data which        identifies physiological and/or anatomical characteristics of        the patient; and 2) provide the electrical signal for        controlling the redistribution component and/or for presenting        the physiological and/or anatomical characteristics for a user        based on the patient data or a standard response, and.    -   means for detection of blood vessels and motorized means for        introduction of the catheter into an artery.

This device is useful not only in patients that have suffered a heartattack but also in patients where the supply of oxygenated blood to thebrain and heart is inadequate for other reasons. An example is a patienthaving an asthma attack; in such a patient, the device of the inventioncan provide for rational distribution of the reduced amount of oxygen,which is available while the patient's respiratory system is compromisedduring the asthma attack.

When automatically operated, the redistribution operates in a predefinedvalue, e.g. based on universal threshold values not directly connectedto a specific patient, but the same may be attained if using manualoperation—in that case the redistribution is controlled manually (e.g.by manually controlling an occlusion device, e.g. a balloon) in responseto the measured values. Due to the electrically or manually controllableredistribution component and the ability of the computer means toreceive patient data, the device can enable a redistribution taking theindividual's actual aortic specifications into account. In this process,the ability of the computer means to provide electrical signals for theredistribution component (or for a device presenting data to theoperator thereof) enables control of the redistribution componentdirectly based on the received patient data and the predefined reactionpattern. Accordingly, the device facilitates a safe procedure in which acomputer interacts with the patient based on knowledge on not only thepatient but also knowledge regarding the redistribution component.According, the intervention can be predictable and repeatable comparedto the procedure carried out manually based on an intuitiveunderstanding of the patient.

For instance, the device can take the actual placement of a catheterhead into account, whether the catheter is in an intended position orhas ended in an unintended position, withholding occlusion.

The term “redistribution” is in the present context intended to mean anintervention (preferably mechanical) that ensures that the cardiacoutput is preferentially directed to the brain and the heart in order tosupply these two organs with sufficient perfusion of (oxygenated) bloodat the expense of perfusion of other organs that are not highly supplysensitive over a limited time span.

The term “suspended state” is meant to denote a state in a cardiacarrest patient or other patient who is undergoing or to undergotreatment, where neurological damage processes are put to a halt bycontrolled redistribution.

The term “to bridge” is in the present context intended to mean anallowance to expand the time window of intervention for the patient toallow time for diagnostics and treatments and/or as an allowance totransport the patient from one physical location to another and/or anallowance to transfer the patient between the care of differentprofessional groups of people.

The term “attachable” is in the present context intended to mean atissue-device connection that allows for an interface of one thefollowing: Outside a patient, onto a patient, through a puncture orsurgical site and an interface that is implanted inside the patient.

The term “inflation” is in the present description and claims used in abroad sense and also includes a process where an object is expandedwithout literally being filled with a liquid or a gas. It will beunderstood that preferred embodiments of the invention utilise aninflatable aortic expansion member (such as a fillable balloon), butexpansion members that accomplish occlusion of a blood vessel via otherreversible mechanisms are also understood to be “inflated” in the senseused herein. If, for instance, an aortic expansion member occludes anartery by being extended into a configuration that extends the expansionmember's periphery by purely mechanical means, this is still understoodas an inflation herein. Alternatives to inflation in its traditionalsense are discussed infra in connection with the description ofimplantable versions of the device of the present invention.

Due to the combination between an electrically or manually controllableredistribution component and the computer means configured to providethe electrical signal based on the patient data, the device according tothe invention becomes capable of facilitating a risk-mitigating factor.

The electrically or manually controllable redistribution component isattachable to the patient such that its interaction becomes independentof user error. Examples of redistribution components include aorticballoons, patient tilting devices and any other device, which is capableof providing blood redistribution in the patient.

An alternative to the use of such component is a redistributioncomponent, which comprises or consists of an aortic retrograde perfusionpump. Relatively large volumes of aerated blood may be present in theperipheral vessels and making this blood volume accessible to the heartand brain can significantly increase the chances of survival.

The redistribution component can interact with the patient to provideredistribution of the cardiac output by following a predefined reactionpattern that means that a specific control signal provides a well-knownand expected result. In that way, the electrical signal provided by acomputer based on patient data enables a safer and more predictabletreatment.

The computer means may include memory means, e.g. in the form of aso-called flash memory or similar computer memory containingre-definable data or fixed data. The memory means may include apredefined definition of the electrical signal as a response to thepatient data.

In one example, the predefined definition is a function determining theelectrical signal or a representation of the electrical signal as afunction of the patient data, and in another example, the predefineddefinition is in the form of a table containing a representation of theelectrical signal for corresponding patient data.

The patient data may e.g. include parameters selected from the groupconsisting of: aortic blood pressure, aortic blood flow, duration ofcardiac arrest, expiratory CO₂, ECG, blood pressure, compression rateand depth, pulse, respiratory frequency, cardiac output redistributiondegree, aortic O₂ saturation or concentration, cerebral or peripheralsaturation, temperature, fluid administered, pharmaceuticalsadministered, biochemical data and ultrasound imaging.

The electrical signal may control function of the redistribution whichin a controlled manner influence the patient and which is reflected inthe patient data.

The device may further comprise patient data generation means configuredto generate patient data during external cardiac compression carried outon the patient, the patient data generation means configured to generatethe patient data by sensing biosignals from the patient. Examples ofsuch biosignals are aortic pressure e.g. generated during cardiaccompression (heart massage) or aortic blood flow e.g. generated duringcardiac compression.

Accordingly, the patient data generation means may be configured tosense biosignals from a blood vessel or a tissue compartment. Thepatient data generation means may include one or more pressure and/orflow sensors including e.g. traditional pressure sensors and flowmeasuring devices of the kind known in the art.

In one embodiment, the redistribution component comprises an aorticexpansion member, e.g. an aortic balloon with electrically or manuallycontrolled inflation and/guiding means for positioning of the balloon inthe aorta and being capable of expanding e.g. upon introduction of anexpansion fluid medium. In other words the inflation means can beadapted to be capable of being operated manually by a user; this willnormally require that the user is informed by the device about thevalues that the automated version of the device receives. However, inthe most user-friendly versions of the device/system of the inflationmeans is adapted to be capable of being operated automatically.

Particularly, the redistribution component may comprise an elongatedbody extending between a proximal end and a distal end. Herein, thedistal end is that end which is insertable into the patient, and theproximal end is that end which is left outside the patient. Theredistribution component may further comprise inflation means connectedto the aortic expansion member for expanding the aortic expansionmember, e.g. a traditional pump such as a roller or piston pump forpumping a fluid medium into the expansion member.

The expansion fluid medium could be a liquid or gaseous substance, e.g.a saline solution or helium.

The device may further comprise an adaptable tissue protection mechanismconfigured to:

-   -   determine a blood pressure or blood flow present in a blood        vessel of the patient during cardiac compression;    -   determine an aortic expansion member characteristics defining a        degree of expansion of the aortic expansion member based on the        determined blood pressure or blood flow; and    -   to provide an electrical signal for controlling the inflation        means in accordance with the determined aortic expansion member        characteristics.

The expansion member characteristics may e.g. be the pressure inside theexpansion member, it may be a volume of the expansion fluid medium,which is introduced into the expansion member, or it could berepresented by a degree of deformation of the expansion member etc.

The adaptable tissue protection mechanism could be configured todetermine the aortic expansion member characteristics based on thedetermined blood pressure or blood flow multiplied by a predeterminedfactor, e.g. a factor being in the range of 1.0-1.2 times the pressureof the blood in the aorta during cardiac compression.

If the redistribution component is an aortic expansion member, theelectrical signal may e.g. specify a degree of expansion, a timing ofexpansion, i.e. when the expansion member should be expanded, durationof expansion of the aortic expansion member, and/or a timing ofcontraction of the aortic expansion member—i.e. when the expansionmember should be contracted to allow blood flow across the expansionmember to thereby reduce the degree of redistribution of the cardiacoutput.

The device may therefore comprise means for specifying a degree ofexpansion of the expanding member, means for timing of the expansion,means for determining duration of expansion, and/or means for timing ofcontraction of the expanding member. In one embodiment, any of thesemeans are controlled based on the patient data in combination with theabove-mentioned pre-defined definition of the electrical signal.

The device may further comprise a location safety mechanism comprisingat least one first sensor capable of determining a biosignal that ischaracteristic for the aorta of the patient and an electronic circuitconfigured to verify a position of the expansion member in the aortabased on the biosignal. The at least one first sensor may e.g. comprisea pressure sensor or a flow sensor or a force sensor or any other sensorof the biosignals discussed herein.

The first sensor could be located on the redistribution component todetermine the biosignal in a position distal to the aortic expansionmember. Typically, this means located either in a position distal to theaortic expansion member or in connection to a member positioned distalthe aortic expansion member.

The device may be configured to use data from the first sensor incombination with data from sensors located at other locations, e.g. atleast one other sensor located to determine the biosignal in a positionproximal to the aortic expansion member, e.g. a sensor attached to theredistribution component. Typically, this other sensor would be placedcaudal to the first sensor.

The data from the first and other sensors could be diastolic or systolicblood pressure or it can be pressure, force, distance, width, volumeand/or flow.

The location safety mechanism may be configured to determine whether theaortic expansion member is located in a position selected from a groupconsisting of: a pulsating vessel in accordance with being the aorta ofthe patient, a pulsating vessel not in accordance with being the aorta,a pulsating vessel being indeterminate as the aorta of the patient, avenous vessel, a tissue compartment not being a blood vessel, a tissuecompartment indeterminate in location. As an example, the locationsafety mechanism may thereby determine if the aortic expansion member islocated in a renal artery, in tissue outside a blood vessel, in a bloodvessel not being the aorta, and to determine when it is positioned, asdesired, in the aorta.

The device may further comprise a second sensor inside the aorticexpansion member or proximal to the expansion member.

The device may be configured with a feedback loop receiving data from atleast one of the first and second sensor, to control the filling of theaortic expansion member. The feedback loop may e.g. be capable ofcontrolling flow, volume, distance, width, force and/or pressure of theaortic expansion member, hereunder the filling of the member to reach apressure that is the result of a standard the multiplication of thepressure sensed above the member and a predefined factor or interval.

The device may further comprise a first failsafe mechanism, configuredto determine a pressure in the aortic expansion member and to determinea volume of the aortic expansion member, to determine a ratio betweenthe pressure and the volume, and to compare the ratio with an upper andlower threshold value, and to execute a control sequence includingstopping of further inflation of the aortic expansion member ordeflation of the aortic expansion member.

The control sequence could be carried out during a period of e.g. 10-20seconds or longer. Alternatively, the filling is immediately stopped, oralternatively immediately reverted, due to a concern that the membermight not be in the right vessel or tissue compartment.

In addition, the device/system may comprise a transponder andtransceiver system for location verification of the redistributioncomponent (e.g. a catheter) and/or the aortic expansion member (e.g. aballoon). Also a transponder and receiver system may be included todetermine the position of the outer wall of the aortic expansion memberto verify the degree of redistribution. Transponders may be based on anyconvenient and available technology and could be based on RFID (radiofrequency identification) technology, Magnet, NFC (near fieldcommunication) technology; even optical communication is a feasiblepossibility. The relative locations of transponders and transceivers mayvary—the transponder may be integrated into the parts of the system thatare intended for introduction into the patient and the transceivers arein that case located externally, but the opposite arrangement is alsofeasible.

Another means for verification of position is to ensure that theredistribution device exhibits enhanced detectability for ultrasounddetection devices—for instance, the redistribution component may be—atleast partially—coated with a polymer that provides enhanced ultrasounddetection, cf. Tavakoli, S M et al, 2001. (“Paper 401 presented atSociety of Plastics Engineers Annual Technology Meeting SPE Antec2001”). In this type of embodiment, the ultrasound detection apparatusmay be considered a “transceiver” while the polymeric coating can beregarded as a transponder because upon excitation (with ultrasound)emits a signal that can be detected as a result of a predefined reactionpattern of the polymer.

The term “transceiver” is used in the present application in itsbroadest sense to denote a system comprising a signal transmitter and asignal receiver, which may exist as one integrated unit or as separateunits. Likewise, a transponder is used in a broad sense and denotes adevice or composition of matter, which, when exposed to a definedsignal, emits a detectable response signal.

In these additional systems for position verification, either thetransponder or the transceiver is conveniently located on the externalsurface of the patient in a non-invasive manner.

The device may further comprise a user interface for use of selectableoperation of the inflation means, e.g. a control button which controlsoperation of the inflation means directly such that the medicalpractitioner can initiate inflation or deflation of the expansion meansat will.

The device may comprise a halt interface allowing manually selectabledeflation of the aortic inflation member, and the halt interface may beconfigured to execute the deflation over a period of time, such as apredefined number of seconds, e.g. over 1-10 or more seconds. This maycause a smoother and less stressing deflation and thus protect the heartfunction of the patient.

The device may comprise a patient state monitor configured to determinea biosignal representing Return of Spontaneous Circulation (ROSC), andto control deflation of the aortic expansion member based on thedetermined signal.

The device may further comprise an electronic human interface with agraphical or audio user interface configured to provide instructions orinformation related to the location and degree of filling of the aorticexpansion member in the aorta of the patient. The user interface maye.g. be a graphical and/or audible user interface configured to provideinstructions related to placement of the aortic expansion member inaorta of the patient and device and patient status feedback. E.g.“Filling underway”; “Balloon occlusion successful” or “Catheter head isoutside of the aorta. Retract and try again”. If the redistributioncomponent and/or occlusion means is manually operated the instructionsprovided may be more detailed and can e.g. provide details about thestatus of the redistribution efforts to the user.

The device according to the invention may provide the anatomicalverification of placement of the expansive member in an arterial vesselby the use of at least one sensor for determining pressure, flow and/orvolume data significant for pressure, flow and/or volume of a fluidinside the expansive member or inside a blood vessel or tissue of thepatient.

The user interface may communicate with the sensor, and based on signalsfrom the sensor, the device may determine a plausible position of theexpanding member in the body of the patient and provide userinstructions via the electronic human interface based on the plausibleposition.

The computer means may e.g. be configured to compare the pressure; flowand/or volume data with reference input data and based on the comparisonto verify a position of the aortic expansion member in the body. I.e.when the expansion member is in an intended position in the aorta, thecorresponding pressure, flow and/or volume data should be within acertain expected upper and lower limit. If it is outside of thisexpected limit, the user may be notified that the expansion member ispossibly not in correct position or approximated damaging the patientand was therefore stopped. Should the device find another position whichcorresponds to the determined pressure, flow and/or volume data, theuser may be notified, e.g. by a graphical representation of the aortaand the expansion member, which position appears to be the actualposition. Thus the device of the invention may comprise an interactivehuman user guide configured to provide information related to a positionof the aortic expansion member in the patient, the information beingdetermined based on the pressure, flow and/or volume data.

The computer mean can then determine the size and type of blood vesselby analysing the pressure, flow and/or volume data continuously, andactivate a failsafe for some verified positions in the body, therebystopping the redistribution component interaction with the patient.

The computer means can use the input data to determine and deliver thelowest needed impact from the aortic expansion member to accomplish theredistribution and carry out said redistribution.

The invention may thus provide a device with a built-in safetymechanisms for verification of the intervention, to withhold thepotentially damaging effort, the expansion of an occlusion balloonwithin a patient, when and where it ought not to happen—To put thetechnology of ‘suspended state’ in the hands of trainedfirst-responders, not only physicians. This will enable a newintervention that spearheads new opportunities for treatment that is notpossible within the current time window of 10-30 minutes. Thetime-expanding intervention would be initiated in a cardiac arrest onceinitial defibrillation and drug treatment prove useless.

Particularly, the device may be used in e.g. the following protocol,which specifies:

1) Initiate and continue either manual or automatic chest compressions,possibly preceded by administration of tissue protectant e.g.recombinant human erythropoietin. 2) Attempt defibrillation of thepatient. 3) Cardiac arrest won't revert. Decision to use safe device foraortic occlusion. 4) Turn on device. Administer safe aortic occlusionthrough device mechanisms. 5) Attempt to defibrillate the patient againwith the improved hemodynamics after the occlusion. 6) If unsuccessful,potential administration of a vasopressor, e.g. vasopressin. This is aclinical decision based on presumed cause of arrest e.g. anaphylaxis.Repeat administration periodically. Potential administration of avasodilator, e.g. sodium nitroprusside. This is a clinical decisionbased on presumed cause e.g. refractory coronary artery disease.Potential periodic repetition of either drug and/or administrationbefore use of

Device. 7) Cardiac arrest won't revert=>Decision to put patient insuspended state. 9) Potential application of 30-90 degree head down orhead up tilt. 10) Potential application of intravascular 2 degreeCelsius saline solution, surface cooling pads on body, hypothermic totalliquid ventilation and/or administration of muscle relaxant. 12)Potential administration of a vasodilator, e.g. sodium nitroprusside, toimprove suspended state microcirculation. Potential periodic repetitionof vasodilator administration. 13) Transport to Specialist Center. 14)Initiate in-hospital cardiopulmonary bypass, ECMO or deliver e.g.PCI-treatment directly. 15) Potential plasmapheresis or dialysis. 16)Achieve return of patient heartbeat with other means possible. 17)Continuation of cooling for additional 24 hours after return ofheartbeat. 18) Prognosticate the patient after at least 72 hours ofsustained therapy. 19) Continuous monitoring of treatment with e.g.end-tidal CO2, aortic pressure or trend-NIRS measurement, attached fromthe very beginning to evaluate efforts.

To further increase the safety and to provide improved information e.g.related to the position of the aortic expansion member in the body, thedevice may comprise means for ultrasound imaging. Data from such meansmay be used for guidance of the user.

If the aortic expansion member is an aortic occluding balloon, thedevice may comprise means for filling the aortic occluding balloon witha liquid, e.g. with saline, or a gas, including e.g. helium or CO2, andmeasuring the aortic pressure and balloon pressure. In an interestingembodiment, the device further comprises a handheld unit comprising thecomputer means and the filling means and being attachable to the aorticoccluding balloon. In another interesting embodiment, the device furthercomprises a human interface unit comprising the filling means and beingattachable to the aortic occluding balloon, said human interfaceoptionally being attachable in a fixed position on a patient and whereinsaid human interface is optionally integrated with the human interfacedescribed above or with the handheld unit. In both cases, the aorticoccluding balloon can be pre-attached to the handheld unit.

When the human interface is being attachable in a fixed position, it isconvenient according to the present invention that the interface canaccommodate the shape of the underlying surface of the patient or aphysical surface in the vicinity of the patient. It also convenient thatthe interface can accommodate to external pressure exerted on the outersurface of the patients (e.g. when the interface is introduced thepatient's surface and other equipment attached—such as a pelvic splinteror pelvic sling—to the patient). This capability of accommodation cane.g. be achieved in preferred embodiments where selected parts of theinterface are comprised of a flexible material, such as a soft plasticmaterial, where an adhesive is present on the patient engaging part ofat least parts of the flexible material.

The computer means could be configured not only to communicate theelectrical control signals to the redistribution component but also toreceive input data from the redistribution component. The redistributioncomponent may include a sensor function e.g. specifying faults, orproviding data relevant for controlling the redistribution component.Such data may include data indicating a lack of expansion, use of theredistribution component, e.g. the number of expansions andcontractions, which have been attained.

The device may further comprise a component attachable to the patientand being configured to administer fluids and drugs to the patient. Theadministering of such fluids and drugs may be controlled by the computermeans of the device, and feedback regarding the administration of thefluids or drugs may be provided via the aforementioned electronic userinterface.

The component for administering fluids and drugs to the patient may e.g.be configured for administering timed and controlled amount of fluidsand/or drugs.

The device may further comprise additional components, e.g. componentsfrom the group consisting of: a patient monitor, a vitals signs monitor,a watch, an external chest compression device, a respirator, an ECGmonitor, a defibrillator, a pacemaker, a pH measurement device, anultrasound device, an ECMO/ECLS device, a body cooling device, aninfusion pump, a capnograph, a ventricular assist device, a dialysisdevice, touchscreen and a telecommunications device. An interestingembodiment, when the device integrates a defibrillator is to include inthe catheter carrying the occlusion device at leas one electrode thatallows the establishment of a voltage difference between the catheter(i.e. the interior of a vessel such as the aorta) and an externalelectrode, e.g. place on the anterior chest wall.

The redistribution component may comprise means for tilting the patientin a head down tilt orientation or for tilting the patient in a head upposition. The first may provide a sometimes advantageous increase inblood pressure in the redistribution compartment, whereas the latter mayalleviate the resistance against the venous blood leaving the brain andheart. Both of these may be advantageous for a patient in aredistributed state depending on how the patient's physiology presentsitself in this new type of treatment.

The device may further comprise means for a self-test system, doublecircuitry, and usage event data recording.

In interesting embodiments the device of the invention is able toreceive a signal of, or being able itself sense that the patient is in astate of cardiac arrest or reduced cardiac output, the device being ableto respond to that state with an increase in blood flow and/or pressuretowards the cranial side of the patient, through a separate member, orthrough a part of the device being intravascular. In other words, inthis embodiment the device is adapted to be permanently present(implanted) in a patient (typically a patient likely to suffer fromcardiac arrest). In this embodiment, the device can respond to adecrease in blood pressure and/or blood flow and/or heart rate and/orany other relevant indication of cardiac arrest and automatically effectredistribution of cardiac output so as to preferentially supply theheart and brain. It is especially preferred in this embodiment that thedevice acts in coordination with e.g. a cardiac pacemaker or otherimplanted devices in order to further enhance chances of survival.Conveniently, the device is capable of signalling to an external sourcethat the patient is said state, e.g. to alert EMS to locate and attendthe patient.

So, a separate aspect of the present invention is a device as disclosedherein, where the device is adapted to be delivered to and implantedwithin a human body. Typically, such a device will be present in thepatient in a “resting state” and will only become active to effectredistribution when the patient's physiological state so demands, forexample when the systolic blood pressure drops below a predeterminedvalue over a period of time considered to be relevant for intervention.Relevant positions of the redistribution component and the occlusioncomponent will be the descending aorta (preferably in suprarenal segmentof the descending aorta).

Such an implantable version will have to be anchored in a position so asto be permanently attached in the position where it can become active.For instance, the device can be anchored using struts or have anexpandable frame as the ones known from implantable stents and valves orsimilar systems known by the skilled person.

Also, such an implantable version will have to be able—on demand—toocclude the vessel where it is positioned and hence need to include apower source—e.g. a battery or a capacitor; also the necessary sensorsof the device need to be powered to provide correct measurements ofrelevant physiological parameters. The power sources may berechargeable, e.g. via induction or other wireless energy transmission,but the device may also include a minor turbine (e.g. with or without arotable impeller) driven by the blood-flow. Also, the patient may havean implanted electrical wire that can supply the necessary re-chargingpower.

The occlusion exerted by the implantable version can be attained inseveral ways: the occlusion component may be a motor-driven mechanicaliris or other mechanical device such as a motor-driven shuttercorresponding to those found in a camera. Alternatively, controllablevalves that are released upon an adequate signal can provide thiseffect. Finally a balloon which is expanded by the patient's blood is apossibility as is use of reversible gas generation process (classicalelectrolysis). It will be understood that occlusion attained in this waymay also be useful in the non-implantable versions of the device of theinvention and that the methods for attaining the occlusion areconsidered “inflation” of an expansion member as discussed above.

As with other devices according to the invention, the implantableversion can be configured to be catheter-deployable by methods generallyknown in the art, cf. e.g. the methods described by Procyrion, cf. US2014/0128659.

An implantable device of the present invention is schematically setforth in FIG. 14.

During insertion, there may exist a safety risk if each procedure stepis not carried out correctly and finalized before the next procedurebegins. Particularly during insertion of the aforementioned elongatedbody constituting in one embodiment the redistribution component, it isof particular importance to ensure a systematic insertion approach.

Accordingly, the device may comprise an aortic detection and puncturemeans configured for attachment to the patient and being configured tooperate in at least five distinct operation phases including a vesseldetection phase, a vessel puncture phase, a vessel insertion phase, acatheter dilatation phase, and a confirmation phase. Data related to onephase may be stored and used subsequently when carrying out the nextphase.

As is apparent from the above, the inventive device is configured withmeans for detecting the location of blood vessels and (motorized)introduction of a cannula into an artery. For instance, the device cancomprise 1) means for motorized movement of a percutaneous cannula (in adirection parallel to a patient's surface, i.e. the movement is sidewaysand will not move the cannula along its own axis or along an axis thatbrings it in contact with the patient), which is either in a fixed ormotorized adjustable angle relative to the patient's surface, 2) meansfor the motorized movement of a redistribution component through saidcannula or needle into a patient. Part of the means for motorizedmovement of the redistribution component can be a means for motorizedmovement of the cannula/needle along an axis that introduces it into thepatient.

It is believed that a separate, independent invention is relatedthereto: this independent invention relates to an automated vascularcatheter deployment device; this device is configured with means fordetecting the location of blood vessels, means for the motorizedmovement of a percutaneous cannula, which is in in a fixed or motorizedadjustable angle relative to the surface of a patient, and means for themotorized movement of a catheter through or across said cannula ormotorized movement of a catheter already located inside said cannula orlocated on the outside of said cannula.

In both the specific embodiment of the invention as well as in theautomated vascular catheter deployment device, the detection means willconveniently include at least one means for detecting an artery, inparticular the femoral artery. For example, the detection means mayinclude an ultrasound transmission and/or sensor element, or an elementfor near infrared or infrared imaging. The motorized movement systemwill typically be configured to allow the component for the motorizedmovement of the cannula to move attached to a motor that travels on arail in housing or a frame that is attached to the patient. Hence, thecannula will move in the manner of the print head nozzles of an inkjetprinter, e.g. through a step motor, pneumatic motor or hydraulic motor.

In one specific embodiment, the automated vascular catheter deploymentdevice is situated in a housing or frame that can be attached to theupper part of the frontal part of a patient's thigh (the part thatcovers A. femoralis). In the housing or frame, the vessel detectionmeans will—when activated—scan an area between the medial and lateralside of the frontal face of the upper part of the covered region toidentify the location of the most likely candidate for the femoralartery. Based on this location determination, the cannula is moved by amotor on its rail to point directly towards the identified artery.Subsequently, the cannula is introduced by motorized action into theartery and finally the catheter is automatically inserted. The cannulainsertion system of US 2009/0275823 or US 2011/0301500 both are usefulimplementation of the part of the system for introduction of theCannula.

Also, the automated vascular catheter deployment device may be situatedin a housing or frame configured to be applied to other positions onhuman limbs, e.g. selected from one or more members of the groupconsisting of the frontal part of the thigh, the frontal part of thepelvis, the frontal part of the groin, the wrist, the frontal part ofthe arm, the frontal part of the arm, and the frontal part frontal partof the neck. In the cases where the automated catheter deployment deviceis used to introduce the device of the invention for providingresuscitation or suspended state, the housing or frame is configured tobe applied one or more members of the group consisting of the frontalpart of the thigh, the frontal part of the pelvis, and the frontal partof the groin, i.e. those locations where it is possible to get access toA. femoralis.

A detailed figure showing embodiments of the automated vascular catheterdeployment device is set forth in FIG. 15.

The computer means of the device/system of the invention may be adaptedto communicate with at least one other therapeutic and/or monitoringdevice so as to allow coordination of the operation of said therapeuticdevices (or simply coordination with other therapeutic measures) and thedevice according to any one of the preceding claims. This at least oneother therapeutic and/or monitoring device is preferably selected from acardiac resynchronization therapy device, a cardioverter-defibrillator,and a cardiac pacemaker; another possibility is a capnograph, i.e. adevice for measuring CO₂ pressure or saturation in exhaled breath.

Examples of coordination between therapeutic devices could e.g. be thecoordination between timing of defibrillation and the control of thedegree of occlusion exerted by the aortic expansion member—it could e.g.be relevant to relax the aortic expansion member immediately prior todefibrillation in order to avoid exposure of the heart to an excessiveafterload. Also it is possible for certain patients to relax theocclusion immediately after defibrillation—again to avoid an excessiveafterload.

In situation where chest compression are administered automatically itis also of relevance to control the cessation of automatic compressionsin coordination with the degree of redistribution, e.g. the occlusionexerted by the occlusion device—the aortic expansion member may e.g. berelaxed following cessation of automatic chest compression and prior todefibrillation in order to optimize the chances that the heart willreturn to spontaneous rhythm, because this order of events decreases themechanical irritability of the heart.

The computer means may also receive and process signals from adevice/means (either separate or integrated into the device and systemsof the invention) that gauges a central venous pressure, therebyenabling calculation of the coronary perfusion pressure (CPP) in apatient and presenting the CPP as part of the output in thedevice/system of the invention—the CPP is calculated from the receivedsignal of a measured central venous pressure and a measured aorticpressure.

A convenient way of achieving coordination with a defibrillator is tointegrate defibrillating capability into the device of the invention.From a practical viewpoint, it is by this embodiment ensured that theelectric shock provided during defibrillation will be present in therelevant anatomical region and thereby it is enabled to usesubstantially lower electric power than in the situation where externalelectrodes are applied. In practice, the device of the invention caninclude one or both of the defibrillation electrodes—the latterembodiment will typically include use of a second, external, electrodepositioned on the patient's body so as to ensure that defibrillationestablishes a short-lived electric circuit through the hearts. Theskilled artisan will know where to optimally place the second electrode.

One particularly preferred embodiment of the present invention is adevice or system for providing resuscitation or suspended state throughredistribution of cardiac output to increase supply to the brain andheart for a patient, the device comprising

-   -   an electrically or manually controllable redistribution        component in the form of a catheter attachable to the patient        and being configured to interact with the patient to provide        redistribution of the cardiac output to increase supply to the        brain and heart, the redistribution component following a        predefined reaction pattern based on an electrical signal,    -   computer means configured to 1) receive a patient data which        identifies physiological and/or anatomical characteristics of        the patient; and 2) provide the electrical signal for        controlling the redistribution component and/or for presenting        the physiological and/or anatomical characteristics for a user        based on the patient data or a standard response, and.    -   means for detection of blood vessels and motorized means for        introduction of the catheter into an artery        wherein    -   the redistribution component comprises 1) an elongated body        extending between a proximal end and a distal end, the distal        end being insertable into the patient, and 2) an aortic        expansion member and inflation means connected to the aortic        expansion member for expanding the aortic expansion member,    -   said device comprises a location safety mechanism comprising at        least one first sensor capable of determining pressure distal to        the aortic expansion member, where the pressure is        characteristic for aorta of the patient, and an electronic        circuit configured to verify a position of said expansion member        in aorta based on said pressure,    -   said device optionally comprises at least one second sensor of        pressure inside the aortic expansion member or proximal to the        expansion member, and    -   said device is configured with a feedback loop receiving        pressure data from at least one of said first sensor and        optional second sensor to control the filling of the aortic        expansion member so as to control the pressure of the aortic        expansion member.

This particular embodiment takes advantage of the dual use ofmeasurements from the first sensor. As detailed herein, the first sensoris in embodiments capable of determining the (blood) pressure in aposition distal to the aortic expansion member. When the redistributioncomponent, e.g. the catheter, is correctly inserted, this measurementwill when the expansion member has occluded the aorta provide for theaortic pressure, which will vary synchronously with the heart rate ormanual chest compressions. If incorrectly inserted (e.g. into a renalartery), the measurement from the first sensor will be constant(typically around zero) after the expansion member has occluded theblood vessel—thus, the measurement immediately indicates that thecatheter has been incorrectly positioned and the occlusion by theexpansion member can be terminated. In other words, the measurement fromthe first sensor provides a direct indication of correct or incorrectinsertion of the redistribution component and aortic expansion member.At the same time, the measurements from the first sensor indicates thepressure that at least has to be exceeded by the aortic expansion memberwhen engaging with the aortic wall in order to occlude the aorta. Butthis provides the advantage that this occluding pressure can be attainedbut not exceeded to too high a degree; there by it can be prevented thatthe aortic occlusion is made with such a high pressure or force on theaortic wall that the tissue would be damaged.

METHODS OF THE INVENTION

As will be apparent from the claims, the presently described device isuseful in methods for providing resuscitation or suspended state in ahuman cardiac arrest patient, said method comprising subjecting thepatient to heart massage (chest compression which may be manual oraccomplished by use of a mechanical chest compression device) while atthe same time ensuring redistribution of the cardiac output topreferentially supply blood to the brain and the heart; these methodsthat are detailed in the claims need not necessarily utilize the deviceof the invention as will also be apparent from the claims. In otherpatients, where the heart action is not compromised, but where the heartand/or brain receives insufficient amounts of oxygenated blood such asin patients suffering from acute asthma attacks, the chest compressionsare dispensed with, since it is only necessary to ensure properredistribution of the blood.

It is nevertheless preferred that methods for resuscitation or suspendedstate provision in a human entails deploying the device according to theinvention by introducing the redistribution component of said deviceinto the aorta of said human (preferably via the femoral artery) andexpanding the aortic expansion member so as to occlude the descendingaorta, thereby redistributing the cardiac output to preferentiallysupply blood to the brain and the heart

In said methods, the redistribution is typically accomplished by atleast one of the following:

-   -   occlusion of the aorta caudal to the left subclavian artery;    -   head-down or head up tilting of the patient so as to reach an        angle of between 30 and 90 degrees relative to the horizontal        plane;    -   applying an external compression force onto the abdomen and/or        thigh(s) and/or arm(s) so as to reduce the perfusion distal to        the external compression force;    -   passively raising the legs to reach an angle between 30 and 90        degrees relative to the horizontal plane.

The method may be combined with at least one of the following treatmentsof the patient:

-   -   administration of fluids, including saline and buffers such as        bicarbonate,    -   administration of vasopressive drugs, including vasopressin and        analogues,    -   administration of a tissue-protecting agent, such as        erythropoietin;    -   administration of anti-arrhythmic drug, such as amiodarone;    -   reduction of body temperature, such as by use of cold IV-fluid        infusion, cooling catheters, transnasal evaporative cooling,        extracorporeal cooling or total liquid ventilation with        temperature controlled perfluorocarbons. This may be done        repeatedly, optionally according to a fixed sequence.

The method according preferably comprises that redistribution isaccomplished by occlusion of the aorta caudal to the left subclavianartery and even more preferred by use of a device of the invention forthis purpose. For instance, occlusion can be accomplished by introducinga device of the present invention into the aorta, preferably via thefemoral artery, and subsequently decreasing or interrupting the bloodflow distal to the redistribution component by expanding theredistribution component of said device. In this embodiment it ispreferred that the redistribution component is expanded in a controlledmanner in response to measurement(s) that indicate the degree ofocclusion and correct placement of said device in the patient's aorta.As indicated above in the discussion of the device of the invention,this occlusion and placement may be fully automated or manuallyoperated. The measurements are typically selected from the groupconsisting of:

-   -   duration of expansion redistribution component usage;    -   blood flow passing by the redistribution component;    -   blood pressure distal of the redistribution component,        optionally combined with blood pressure proximal to the        redistribution component;    -   aortic O₂ saturation distal of, and preferably in close        proximity to, the redistribution component, optionally combined        with arterial O₂ saturation proximal of the redistribution        component.

It is preferred that expansion of the redistribution component iscontrolled manually or by the computer means of the device to avoidincorrect positioning or expansion degree of said device and byactivating the failsafe of claim 9 in case said device is verified to beincorrectly positioned thereby interrupting the expansion of theredistribution component to allow subsequent correct positioning. Inbroad terms, the method preferably includes means and measures thatavoid incorrect redistribution of blood flow.

In certain embodiments redistribution is temporarily interrupted atregular or irregular intervals so as to ensure sufficient perfusion ofall parts of the body of the patient. However, some caution must beexercised due to spontaneous dilation of blood vessels in thenon-perfused part of the body during the redistribution, meaning thatreestablishment of the redistribution state can be difficult.

The method of the invention may act during or as a bridge to one or moreof therapeutic hypothermia; angioplasty, including PCI and angiography;dialysis; administration of drugs such as vasopressors, thrombolyticdrugs such as fibrinolytics, fluids, bicarbonate, antidotes, andantiarrhythmic drugs; the use of ultrasound, X-ray, CT, or MR;intubation; mechanical ventilation; ventricular assist devices; hearttransplantation, including artificial heart transplantation; surgery,including CABG surgery and valve surgery; blood transfusion; placementof external or internal pacemaker or ICD; catheter ablation;thromboendarterectomy; defibrillation; transportation; ECMO; ECLS andcardiopulmonary bypass. In other words, the method may be combined withany one of a number of other methods that are commonly used inresuscitation.

The method may further comprise that the restriction on perfusiondelivered to the brain and heart is lowered through the use of avasodilator, hereunder specifically sodium nitroprusside ornitroglycerin and repeated administration of sodium nitroprusside ornitroglycerin, hereunder repetition in intervals of 2-10 minutes. Thismay be combined with the use of an aortic expansion member to preventthe systemic vascular collapse caused by the vasodilator.

The method of the invention can also be combined with the use of any oneof the following: active compression-decompression CPR, an impedancethreshold device, adenosine administration, controlled pauses in the CPR(e.g. compressions for 20 seconds, then a pause in compressions for 20seconds.)

A related method of the invention for providing resuscitation orsuspended state through redistribution of cardiac output to increasesupply to the brain and heart for a human in cardiac arrest or imminentcardiac arrest comprises subjecting the patient to external chestcompression while at the same time ensuring redistribution of thecardiac output accomplished by occlusion of the aorta caudal to the leftsubclavian artery, and comprising lowering the restriction on perfusiondelivered to the brain and heart through the use of a vasodilator,hereunder specifically sodium nitroprusside or nitroglycerin, hereunderrepetition in intervals of 2-10 minutes. Also this method may act as abridge to one or more of the following:

ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI andangiography; dialysis; therapeutic hypothermia, hereunder cold IV-fluidinfusion, cooling catheters, transnasal evaporative cooling,extracorporeal cooling or total liquid ventilation; administration ofdrugs, hereunder vasopressors or vasodilators, hereunder sodiumnitroprusside or nitroglycerin, thrombolytic drugs such asfibrinolytics, fluids, bicarbonate, antidotes, tissue-protecting agentsand antiarrhythmic drugs, such as amiodarone; the use of ultrasound,X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assistdevices; surgery, including CABG surgery and valve surgery; bloodtransfusion; placement of external or internal pacemaker or ICD;catheter ablation; thromboendarterectomy; heart transplantation;defibrillation; transportation.

A second related method for providing resuscitation or suspended statethrough redistribution of cardiac output to increase supply to the brainand heart for a human in cardiac arrest or imminent cardiac arrest,comprises subjecting the patient to external chest compression while atthe same time ensuring redistribution of the cardiac output accomplishedby sustained abdominal compression or abdominal binding, and comprisinglowering the restriction on perfusion delivered to the brain and heartthrough the use of a vasodilator, hereunder specifically sodiumnitroprusside or nitroglycerin, hereunder repetition in intervals of2-10 minutes, and comprising acting as a bridge to one or more of thefollowing:

ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI andangiography; dialysis; therapeutic hypothermia, hereunder cold IV-fluidinfusion, cooling catheters, transnasal evaporative cooling,extracorporeal cooling or total liquid ventilation; administration ofdrugs, hereunder vasopressors or vasodilators, hereunder sodiumnitroprusside or nitroglycerin, thrombolytic drugs such asfibrinolytics, fluids, bicarbonate, antidotes, tissue-protecting agentsand antiarrhythmic drugs, such as amiodarone; the use of ultrasound,X-ray, CT, or MR; intubation; mechanical ventilation; ventricular assistdevices; surgery, including CABG surgery and valve surgery; bloodtransfusion; placement of external or internal pacemaker or ICD;catheter ablation; thromboendarterectomy; heart transplantation;defibrillation; transportation.

During development work of the present invention, the inventor hasrealized that the controlled occlusion of blood vessels that is obtainedby the device of the present invention has a wider range ofapplications.

For instance, when performing surgery of a patient where excessivebleeding occurs, it may be inexpedient to interrupt the bleeding bytraditional means (such as compression or suture of influent bloodvessels), since some patients' vasculature may be too fragile and/or tosclerotic to allow such approaches. In such patients the introduction ofan occlusion device, which in principle functions and is operated likethe above-discussed aortic expansion member, but is dimensioned so as tobe able to expand and safely occlude smaller vessels, is believed toprovide a much less traumatic way of preventing blood from reaching thetraumatized area where bleeding occurs.

So in a separate aspect of the invention is provided a method forstopping or reducing bleeding from tissue(s) or organ(s) during surgeryof said tissue(s) or organ(s), the method comprising inserting anocclusion device into a blood vessel, which supplies said tissue(s) ororgan(s) with blood, wherein said occlusion device is reversiblyexpanded to occlude said blood vessel and wherein the pressure exertedby the expanded occlusion device on the wall of the blood vessel isadapted to be between 1 and 2 times the vascular pressure differenceacross the occlusion device.

Typically, the pressure exerted by the expanded occlusion device on thewall of the blood vessel is adapted to be at most 1.5 times the vascularpressure difference across the occlusion device, such as at most 1.3, atmost 1.2, and at most 1.1 times; the important goal to reach is to nottraumatize the vascular wall, and in certain embodiments, the occlusiondevice is expanded up to exactly or just above the point where thepressure is sufficient to prevent blood from passing the device in theblood vessel.

The occlusion device will typically include or be attached to at leastone vascular pressure sensor, which can determine the vascular pressurein said blood vessel. Such a pressure sensor can be positioned in saidvessel between the occlusion in said vessel and said tissue(s) ororgan(s) and/or positioned in the part of said vessel which is separatedfrom said tissue(s) or organ(s) by the occlusion. In the first case, theocclusion device is sufficiently expanded when the pressure sensor canno longer measure fluctuations in vascular pressure, in the second case,the occlusion device is sufficiently expanded when the pressure exertedon the vessel's walls by the device is equal to or slightly higher thanthe measured vascular pressure.

In an embodiment related to the invention is provided a method forstopping or reducing bleeding from tissue(s) or organ(s), hereunderduring e.g. surgery or other situations where bleeding occur of saidtissue(s) or organ(s), the method comprising inserting an occlusiondevice (such as a device of the present invention) into a blood vessel,which supplies said tissue(s) or organ(s) with blood, wherein saidocclusion device is reversibly expanded to occlude said blood vessel andwherein the pressure exerted by the expanded occlusion device on thewall of the blood vessel is adapted to be between 1 and 2 times thevascular pressure difference across the occlusion device. In thisembodiment, use is made of the same pressure measurements and controlsthat define the device of the invention but the pressure measurementsare interpreted to provide for a different use, namely to induce arrestof bleeding of an organ. The advantage is that the vessels which areoccluded are not subjected to excess stress, thus preventing damage tothe vessels under such operation.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

In the following, embodiments of the invention will be described infurther details with reference to the drawing in which:

FIG. 1 illustrates a device according to the invention;

FIG. 2 illustrates functions of a device according to the invention;

FIG. 3 illustrates a user interface;

FIG. 4 illustrates a digital sensing component;

FIG. 5 illustrates software functions;

FIGS. 6-7 illustrate an aortic expansion member;

FIG. 8 illustrates a user interface screen on a PC;

FIG. 9 illustrates placement in a human being;

FIG. 10 illustrates attachment of the device to a limp of a patient;

FIG. 11 illustrates a retrograde pump; and

FIGS. 12a-12e illustrate an implanted device.

FIG. 13 illustrates an arrangement of a catheter for use in theinvention in a state ready for insertion.

FIG. 14 illustrates embodiments of implanted devices of the invention.

FIG. 15 illustrates an automated vascular catheter deployment device.

Further scope of applicability of the present invention will becomeapparent from the following detailed description and specific examples.However, it should be understood that the detailed description andspecific examples, while indicating preferred embodiments of theinvention, are given by way of illustration only, since various changesand modifications within the scope of the invention will become apparentto those skilled in the art from this

DETAILED DESCRIPTION

Redistributing the cardiac output during cardiac arrest may be carriedout with the device illustrated in FIG. 1, performing e.g. according tothe algorithm structure illustrated in FIG. 2, and working inconjunction with a human user interface as illustrated in FIG. 3.

FIG. 1 illustrates a device 1 which contains a piston pump, a fluidcontainer, power supply with batteries, a CPU, RAM, Memory with computerprogram code for the CPU, and power driven motor means for operating thepiston pump.

The device is capable of providing resuscitation or suspended statethrough redistribution of cardiac output to increase supply to the brainand heart for a patient. The illustrated device comprises anelectrically or manually controllable redistribution component in theform of an occlusion catheter sub-part 2 suitable for insertion througha femoral arterial line

The occlusion catheter facilitates redistribution of the cardiac outputby reducing blood flow across a balloon which is inflated in the aortaand thereby increases supply to the brain and heart.

The device is adapted for automatic operation. The CPU is configured toreceive a patient data which identifies physiological and/or anatomicalcharacteristics of the patient and to provide the electrical signal forcontrolling the redistribution component and/or for presenting thephysiological and/or anatomical characteristics for a user based on thepatient data or a standard response. In the illustrated embodiment, theocclusion catheter comprises two sensors, one being above the balloonand one being inside the balloon, or alternatively below the balloon.The sensor may particularly be pressure sensors which can provide bloodpressure which herein is considered as patient data. These patient datamay be generated e.g. during external cardiac compression carried out onthe patient.

The signals from the sensors are transmitted to the CPU which, based onthe computer program code, controls checks the location of the catheterin the aorta and the patent safety during use of the device and whichcontrols the filing of the balloon. The CPU thereby follows a predefinedreaction pattern based on the electrical signal from the sensor.

The device has a screen 3 which forms part of a user interface. The userfurther comprises control buttons and visual feedback through LED lightsand/or text display. As illustrated in FIG. 1, the user interface mayinform the user when filling is underway, and it may further inform theuser about a successful balloon occlusion and thus cardiac outputredistribution or alternatively that the catheter is not at the desiredlocation in aorta.

The digitally sensing catheter sub component may be designed asillustrated in FIGS. 4a and 4b . FIG. 4a is a transverse view and FIG.4b is a longitudinal view. The structure and location of the sensorsrelative to the catheter may be as illustrated in FIG. 4.

The catheter body comprises an elongate tube 4 with a lumen 5 whereinsaline can flow in both directions, i.e. both to and from the balloonand wherein the sensor units 6, 7 and sensor wires 8 can pass throughthe extent of the catheter body, as illustrated in FIG. 4. The catheterbody may be constructed from PEBAX with a working length of 75 cm. Thesensors are separated by a sealing, e.g. glue, 9.

The balloon (not shown) can be made from low durometer urethane, with awall thickness of 0.05 mm, an overall length of 30 mm, and a diameterfrom 20-40 mm depending on filling degree, having a burst pressure of atleast 500 mmHg.

The balloon may be configured in size to occlude the aorta of thepatient.

The sensors may pressure sensors of the type MEMS, e.g. MEMS pressuresensor, MEM2000, Metallux Switzerland.

The sensors can be interfaced with a print circuit board via USB. TheUSB connection allows for the signal to be processed digitally and usedas input for the software algorithms as illustrated in FIG. 2 and FIG.5.

The device further comprises a controller component. The controllercomponent may contain a membrane keyboard with LEDs for user interface,integrated circuit, a pump, hereunder e.g. a piston pump or roller pump,battery, and any other additional component for controlling, powering,or operating the device in accordance with the invention.

In the embodiments of the device of the invention where a roller pump(i.e. a peristaltic pump) is included, it is of particular importance toavoid deformation and/or loss of function (due to e.g. “shape memory” ofthe polymer of the tubes) during storage of the flexible tubes withwhich the rollers are in contact during operation of the device. It isenvisaged that the device may be stored for prolonged periods of time(e.g. in a rescue vehicle) before it comes into use, and in the eventthe flexible tubes were constantly compressed by the rollers in theroller pump during storage, the operation of the device could beseriously compromised due to changes in shape of the tubes. One solutionto this problem provided by the present invention is to ensure that thetubes are not compressed by the rollers during storage by including amechanism that prevents the rollers from being in contact with the tubesduring storage but which can render the rollers operational and bringthem in contact with the tube(s) at the time of operation. One simplesolution is to secure the roller heads in fixed positions duringmanufacture by e.g. a spring load mechanism, which can be easily removed(e.g. by removal of a pin from a socket) and thereby allow the rollerhead(s) to attain functional position(s): Typically, rollers in a rollerpump are pushed towards the tube wall by a spring mechanism, and whenpackaging the device, the springs of this mechanism can be compressed sothat the rollers are kept in a locked position.

Another issue related to the potential prolonged storage times is thefact that tubing, in particular catheters, may attain an undesired shape(again due to shape memory of soft plastic polymers) due to the physicalshape of the storage package. Solutions to this have been devised in theprior art—for instance, U.S. Pat. No. 7,670,331 describes systems forensuring correct shape of catheters upon insertion after prolongedstorage. In the present invention, catheter tubes are typically storedby folding the catheter tube in a “J” or “U” shape to ensure that onlythe parts of the tubing where shape memory is an insignificant problemwill be folded during storage.

Another embodiment of the invention is illustrated in FIG. 11. In thisembodiment, the catheter component 15 of the device further compromisesa retrograde pump 16 controlled by controlled by communication with theCPU contained in the external part 17 of the device. The pump could be abrushless type pump such as brushless EC6 motor from Maxon, Maxonprecision motors Inc. The pump is located in the aorta 18.

The catheter subpart may be inserted into the aorta of the patient bylocating and puncturing the femoral artery and by inserting the devicethrough the defined opening. The device could be used for the puncturingand placement procedures and these procedures may be integrated into thedevice. The device can aid the user from unintended harmful eventsoccurring to the patient through the active security mechanism modesillustrated in FIG. 5.

The controller component of the device can be attached or fixed to theleg 10 of a patient through e.g. a wraparound leg belt or an adhesivefixation pad. FIG. 10 illustrates an embodiment where the device 11 isstrapped to the patient with a strap 12 or fixed to the patient by anadhesive 13. In both embodiments, the catheter 14 extends into the aortathrough a sealed port.

In another embodiment of the invention, the device can be implanted intoa patient. This device may function through wireless coordination andelectricity transfer between the device and a pacemaker, ICD or similarimplantable cardiovascular diagnostic or therapeutic medical device, asillustrated in FIGS. 12a -12 e.

FIG. 12a illustrates a heart 19 with a pacemaker/ICD 20 communicatingsignals with a redistribution component 21. In FIGS. 12b and 12c , theredistribution component is a pump, and in FIGS. 12d and 12e , theredistribution component is an occlusion balloon 22.

In another embodiment of the invention which is detailed elsewhereherein, the device functions as part of a robotic puncture and insertionsystem, further decreasing the room for user error. In other words, thedevice is integrated with automated means for vessel recognition

Expectedly, the system includes a variation of the above configurationsand modes.

In certain embodiments, the device of the invention is stored prior touse as a sealed outer compartment comprising a protection cover for theoutside of the display and parts of the device that come into directcontact with the patient and an inner compartment which comprises themajority of the functional components (e.g. battery, CPU, pump,circuitry, memory, tubing, actuator etc.). These two compartments can bestored separately from the parts introduced into the patient, or theparts introduced into the patient may be part of the outer compartment.This arrangement of components allows that the outer compartment and itscomponents can be readily removed for later destruction/disinfectionafter use and that the inner compartment and its components can bepartially recycled or refurbished. One convenient arrangement is in theform of an “oyster” package, where the two compartments are disengagedimmediately after use.

Typically, connectors between the insertable parts (cannulas, cathetertubes) are those state of the art connector systems that ensure sterileconnection in order to avoid contamination of both patient and personneloperating the device.

A preferred embodiment of the invention entails that the redistributioncomponent is in the form of a catheter, which is introduced into thefemoral artery and advanced to the correct position in the aorta. Toensure sterility the catheter is conveniently covered by a sheath thatcan be handled by the end user. The catheter is allowed to more freelyrelative to the inner surface of this sheath, meaning that the cathetercan be advanced stepwise through the entrance cannula by simply grappingthe catheter via the external sheath which is then gradually peeled offtowards the proximal end of the catheter until the catheter iscompletely introduced. To further assist in maintaining sterility, thetip of catheter is embedded in a hollow “grip” (a handling means) thatallows the user to introduce the tip into the entry cannula withoutdirectly touching any part of the catheter.

A specific embodiment of a catheter with sheath and handling means isshown in FIG. 13, where the packaged product is shown after the sheathhas been opened for use. Prior to being opened, the catheter is entirelycomprised inside the sheath to maintain sterility. The sheath is in thisembodiment comprised of two sheets that are welded together at the edgesand which can be separated at least at the end of the package comprisingthe handling means in a manner known per se (by tearing the sheetsapart, e.g. by handling parts of the separate sheets that are not weldedtogether and are positioned in the circumference of the weldedarea)—similar systems are known from e.g. packages containing urinarycatheters. After having separated the two sheets, the user may handlethe “grip” with one hand and the external part of the sheath with theother hand, thus avoiding direct contact with the catheter. The grip maybe used to introduce the catheter tip into a cannula, and the user canslide and push the catheter forward through the cannula by handling thesheath.

EXAMPLE 1 Operation of a Device of the Invention

The device is started by pressing the button ON or it is started byunpacking the device e.g.

by releasing an attachment to the electrical circuit between device andbattery. The user uncovers the catheter and inserts the catheter intothe patient. Once the user has completed the procedure, the user pressesINFLATE, and the system enters the Position verification mode.

Position Verification Mode

When the criteria for the correct position is met, the indicator“Position correct ✓” starts blinking green and the indicator “Pumping ⊙”starts blinking yellow, then the system enters Actuator (inflation)mode.

If the correct position is not achieved or if the correct position islost, then indicator “Pumping ⊙” stops blinking, an alarms sounds and“Retry placement X” starts blinking, until INFLATE is pressed again.

Actuator (Inflation) Mode

The actuator is activated and the balloon is inflated. When the criteriafor a filled balloon is reached the actuator is stopped, the indicator“Pumping ⊙” stops blinking yellow and Self-adjustment mode is entered.

If the criteria are not met after one minute, or the user presses theDEFLATE button, the Deflation mode is entered followed by “Retryplacement X” starting to blink and staying lit until INFLATE is pressedagain.

Self-Adjustment Mode

The indicator “Balloon filled—♦” starts blinking green. Theself-adjustment mode regulates the pressure in the balloon to a correctpressure according to the criteria.

If the criteria can't be held, an alarm sounds, the deflation mode isentered followed by “Retry placement X” starting to blink until INFLATEis pressed again, or if the user presses the DEFLATE button, theDeflation mode is entered.

Deflation Mode

The indicator “Pumping ⊙” starts blinking yellow. The actuator isactivated and the balloon is deflated.

When the balloon is deflated “Balloon deflated—♦” starts blinking blueuntil the user presses INFLATE again.

Glossary

P1 is Pressure sensor 1, as illustrated in FIG. 1, and P2, is pressuresensor 2.

Positioning Criteria

The maximum pressure measured by P1 is above 15 mmHg and has a deltabetween the max and min pressure measured higher than 5 mmHg. 50 Hz.

Filling Criteria

P2 reach the pressure measured by P1×1.20. 50 Hz

Self-Adjustment Criteria

P2 is still within the following range: (P1×1.10)−(P1×1.30). 0.1 Hz.

The device may signal the user with the following visual and/or auditorysignals:

Message A: “ Filling. Continue CPR.”

Message B: “ Retry placement. Balloon is now empty.”

Message C: “ Aorta Occlusion success.”

Message D: “ Deflation done.”

EXAMPLE 2 Simulation Experiment

A model of the human ascending aorta, aortic arch, and common femoralarteries was produced in silicone rubber. The model was submerged inwater and internal pressure (100 mmHg) in the model was applied via aconnected water column. Chest compressions were simulated by manuallyapplying pressure to an attached balloon.

The test device was inserted from an opening in the part of the modelcorresponding to the left common femoral artery so as allow the tip toreach a position corresponding to just proximal of the renal arteries.The occlusion balloon was inflated while recording MEMS pressure sensordata from the tip of the catheter and from the interior of the ballooncompartment.

It was demonstrated that the positioning and occlusion of theredistribution catheter can be controlled and verified through the useof software-hardware integration mechanisms. For example, measuring thecorrect pressures during filling corresponding to the catheter tip beingin the aorta (and e.g. not misplaced in the renal artery) allowspressure control of the filling of the balloon as a function of thepressures intended to be countered. In other words, if the catheter isnot placed in the correct position, filling of the balloon counter theaortic pressure and has the consequence that the pressure measured atthe tip drops to zero instead of remaining at the level of the aorticpressure.

EXAMPLE 3 In Vivo Experiment

A prototype device was tested in two pilot animal trials. The animalswere healthy Danish farm pigs of 30-38 kg, which were sedated usingpentobarbital (Mebumal) 50 mg/ml, 6 mg/kg/h and ketamine (Ketaminol vet)100 mg/ml, 15 mg/kg/h. The animals further were administered 2000 unitesof unfractionated heparin.

The animals were mechanically ventilated and oxygen levels were set to23% oxygen prior to cardiac arrest. During the experiment the animalswere continuously supplied with saline (0.9% NaCl) at an infusion speedof 2 l/h.

Cardiac arrest was induced by applying 9 V DC directly to the heart byelectrodes introduced via the right jugular vein. Cardiac arrest wasdefined as a systolic blood pressure <25 mmHg for more than 5 seconds.

ROSC was defined as a pulsatile rhythm with a systolic aortic bloodpressure >60 mm Hg maintained for at least 5 min.

Arterial blood pressure, venous blood pressure and heart rate weremeasured with intravascular gauges in the aortic arch through the rightcarotid artery at the junction with the aorta, and the right jugularvein entering the central vena cava.

Pig no. 1 had the following baseline values prior to induction ofcardiac arrest: heart rate 85 bpm, arterial blood pressure 98/63 mmHg,venous blood pressure 15 mmHg. After the induction of cardiac arrest,the pig was left in no-flow state for 1 min. Hereafter mechanical chestcompressions were delivered with the LUCAS 2 device (Physiocontrol)continued for an additional 5 min. After the pig had sustained a cardiacarrest for a total of 6 min, the prototype device was introduced to theaorta through the right femoral artery. The parameters after the 6 min.of cardiac arrest were measured as the following: Heart rate 0 bmp, witha mechanical setting at 100 compressions/min, blood pressure was 34/23mmHg, and central venous pressure was 20 mmHg. Hereafter the prototypedevice was turned on and the effect were left to take hold for 1 min.The values were measured to the following regarding 1 min of sustaineduse of the prototype device: Heart rate 0, with a mechanical setting at100/compressions/min, central arterial blood pressure was 59/28 mmHg,central venous pressure was 22 mmHg.

The use of the prototype device demonstrated an increase of the centralarterial pressure, and thus also of the coronary perfusion pressure andcerebral perfusion pressure, from systolic 34 mmHg to 59 mmHg, and asustained venous pressure going from 20 to 22 mmHg. The coronaryperfusion pressure, the central parameter in cardiac resuscitation, iscalculated as the difference between the systolic central arterialpressure and the central venous pressure. We are thus able todemonstrate an increase of the coronary perfusion pressure with 164%.

Pig no. 2 was subjected to the same conditions as Pig no. 1, but cardiacarrest was effected by inducing blood loss (700 ml) by bleeding from theright femoral artery prior to instigation of the treatment.

Pig no. 2 had the following baseline values prior to induction ofcardiac arrest: heart rate 105 bpm, arterial blood pressure 96/42 mmHg,venous blood pressure 12 mmHg. After blood loss the values were: heartrate: 93 bpm, arterial blood pressure: 35/20 mmHg, central venouspressure: 10 mmHg. Treatment was commenced. After 1 minute of treatmentthe values had changed to: heart rate: 95 bpm, arterial blood pressure:55/30 mmHg, central venous blood pressure: 10 mmHg.

Hence, by using the prototype of the invention, it was achieved toobtain a 57% increase the arterial blood pressure, whereas an 80%increase in coronary perfusion pressure was obtained.

NUMBERED EMBODIMENTS

The invention relates in particular to the following consecutivelynumbered embodiments:

E1. A device for providing resuscitation or suspended state throughredistribution of cardiac output to increase supply to the brain andheart for a patient, the device comprising

-   -   an electrically or manually controllable redistribution        component attachable to the patient and being configured to        interact with the patient to provide redistribution of the        cardiac output to increase supply to the brain and heart, the        redistribution component following a predefined reaction pattern        based on an electrical signal, and    -   computer means configured to:        -   receive a patient data which identifies physiological and/or            anatomical characteristics of the patient; and        -   provide the electrical signal for controlling the            redistribution component and/or for presenting the            physiological and/or anatomical characteristics for a user            based on the patient data or a standard response.

E2. The device according to embodiment E1, where the computer meanscomprises memory means having stored therein a predefined definition ofthe electrical signal as a response to the patient data.

E3. The device according to embodiment E1 or E2, comprising patient datageneration means configured to generate patient data during externalcardiac compression carried out on the patient, the patient datageneration means configured to generate the patient data by sensingbiosignals from the patient.

E4. The device according to embodiment E3, where the patient datageneration means is configured to sense biosignals from a blood vesselor a tissue compartment.

E5. The device according to any one of embodiments E1-E4, wherein theredistribution component comprises or consists of an aortic retrogradeperfusion pump.

E6. The device according to any one of embodiments E1-E4, where theredistribution component comprises an elongated body extending between aproximal end and a distal end, the distal end being insertable into thepatient, where the redistribution component comprises an aorticexpansion member and inflation means connected to the aortic expansionmember for expanding the aortic expansion member.

E7. The device according to embodiment E6, wherein the inflation meansis adapted to be capable of being operated manually by a user.

E8. The device according to embodiment E6 or E7, wherein the inflationmeans is adapted to be capable of being operated automatically.

E9. The device according to any one of embodiments E6-E8, furthercomprising an adaptable tissue protection mechanism configured to:

-   -   determine a blood pressure or blood flow present in a blood        vessel of the patient during cardiac compression;    -   determine an aortic expansion member characteristics defining a        degree of expansion of the aortic expansion member based on the        determined blood pressure or blood flow; and    -   to provide an electrical signal for controlling the inflation        means in accordance with the determined aortic expansion member        characteristics.

E10. The device according to embodiment E9, where the adaptable tissueprotection mechanism is configured to determine the aortic expansionmember characteristics based on the determined blood pressure or bloodflow multiplied by a predetermined factor.

E11. The device according to any one of embodiments E6-E10, where theelectrical signal specifies a degree of expansion of the aorticexpansion member, a timing of expansion of the aortic expansion member,an upper limit of expansion, a duration of expansion of the aorticexpansion member, and/or a timing of contraction of the aortic expansionmember.

E12. The device according to any one of embodiments E6-E11, where theinflation means comprises a piston or roller pump.

E13. The device according to any one of embodiment E6-E12, furthercomprising a location safety mechanism comprising at least one firstsensor capable of determining a biosignal which is characteristic foraorta of the patient and an electronic circuit configured to verify aposition of the expansion member in aorta based on the biosignal.

E14. The device according to embodiment E13, where the at least onefirst sensor comprises a pressure sensor.

E15. The device according to embodiment E13 or E14, where the firstsensor is located on the redistribution component to determine thebiosignal in a position distal to the aortic expansion member.

E16. The device according to embodiment E15, where the device isconfigured to use data from the first sensor in combination with datafrom sensors located at other locations.

E17. The device according to embodiment E16, where at least one of theother sensors is located on the redistribution component to determinethe biosignal in a position proximal to the aortic expansion member.

E18. The device according to any one of embodiments E13-E17, where thelocation safety mechanism is configured to determine whether the aorticexpansion member is located in a position selected from a groupconsisting of: a pulsating vessel in accordance with being the aorta ofthe patient, a pulsating vessel not in accordance with being the aorta,a pulsating vessel being indeterminate as the aorta of the patient, avenous vessel, a tissue compartment not being a blood vessel and atissue compartment indeterminate in location.

E19. The device according to any one of embodiments E13-E18, furthercomprising a second sensor inside the aortic expansion member orproximal to the expansion member.

E20. The device according to any one of embodiments E13-E19, wherein thedevice is configured with a feedback loop receiving data from at leastone of the first and second sensor, to control the filling of the aorticexpansion member.

E21. The device according to any one of the embodiments E6-E20, furthercomprising a first failsafe mechanism, configured to determine apressure in the aortic expansion member and to determine a volume of theaortic expansion member, to determine a ratio between the pressure andthe volume, and to compare the ratio with an upper and lower thresholdvalue, and to execute a control sequence including stopping of furtherinflation of the aortic expansion member or deflation of the aorticexpansion member.

E22. The device according to any one of embodiments E6-E21, furthercomprising a user interface for use of selectable operation of theinflation means, wherein said user interface optionally can accommodatethe shape of the underlying surface of a patient or a physical surfacein the vicinity of a patient and/or can accommodate to external pressureexerted on the outer surface of a patient.

E23. The device according to any one of embodiments E6-E22, comprising ahalt interface allowing manually selectable deflation of the aorticinflation member.

E24. The device according to embodiment E23, where the halt interface isconfigured to execute the selectable deflation over a predefined numberof seconds.

E25. The device according to any one of embodiments E6-E24, comprising apatient state monitor configured to determine a biosignal representingReturn of Spontaneous Circulation (ROSC), and to control deflation ofthe aortic expansion member based on the determined signal.

E26. The device according to any one of embodiments E6-E25, furthercomprising an electronic human interface with a graphical or audio userinterface configured to provide instructions or information related tothe location and degree of filling of the aortic expansion member in theaorta of the patient, said human interface optionally being attachablein a fixed position on a patient, wherein said human interfaceoptionally can accommodate the shape of the underlying surface of apatient or a physical surface in the vicinity of a patient and/or canaccommodate to external pressure exerted on the outer surface of apatient.

E27. The device according to any one of embodiments E6-E26, furthercomprising at least one sensor for determining pressure, flow, O₂saturation or concentration, and/or volume data significant forpressure, flow and/or volume of a fluid inside the aortic expansionmember or inside a blood vessel or tissue of the patient.

E28. The device according to embodiment E27, where the computer means isconfigured to compare the pressure, flow and/or volume data withreference input data and based on the comparison to verify a position ofthe aortic expansion member in the body.

E29. The device according to embodiment E27 or E28, where the computermeans is configured to determine the size and type of blood vessel byanalyzing the pressure flow and/or volume data continuously.

E30. The device according to any one of embodiments E27-E29, where thecomputer means is configured to activate a failsafe for some verifiedpositions in the body or limits based on sensor data analysis, therebystopping the redistribution component interaction with the patient, theexpansion of the aortic member or initiation of contraction of theaortic member.

E31. The device according to any one of embodiments E27-E30, wherein aninteractive human user guide is configured to provide informationrelated to a position of the aortic expansion member in the patient, theinformation being determined based on the pressure, flow and/or volumedata.

E32. The device according to any one of embodiments E1-E31, furthercomprising means for ultrasound imaging data in the guidance of theuser.

E33. The device according to embodiment E32, wherein at least part ofthe redistribution component exhibits enhanced ultrasound detectioncapability.

E34. The device according to any one of embodiments E1-E33, whichfurther comprises at least one transponder and transceiver system forlocation verification of the redistribution component and/or of theaortic expansion member.

E35. The device according to any one of embodiments E1-E34, whichfurther comprises at least one transponder and transceiver system fordetermination of the position of the outer boundary of the aorticexpansion member.

E36. The device according to embodiment E34 or E35, wherein at least onetransponder is positioned in the part of the device intended to beintroduced into a patient.

E37. The device according to any one of embodiments E34-E36, wherein atleast one transceiver is positioned in the part of the device intendedto be introduced into a patient.

E38. The device according to any one of embodiments E34-E37, where atleast one transponder or at least one transceiver is adapted to bepositioned on the external surface of a patient in a non-invasivemanner.

E39. The device according to any one of embodiments E1-E38, where thepatient data includes parameters selected from the group consisting of:aortic blood pressure, aortic blood flow, duration of cardiac arrest,expiratory CO₂, ECG, blood pressure, compression rate and depth, pulse,respiratory frequency, cardiac output redistribution degree, aortic O₂saturation or concentration, cerebral or peripheral saturation,temperature, fluid administered, pharmaceuticals administered,biochemical data, and ultrasound imaging.

E40. The device according to any one of embodiments E1-E39, where theaortic expansion member comprises an aortic occluding balloon.

E41. The device according to embodiment E40, further compromising meansfor filling the aortic occluding balloon with a liquid or a gas.

E42. The device according to embodiment E41, further comprising ahandheld unit comprising the computer means and the filling means andbeing attachable to the aortic occluding balloon.

E43. The device according to embodiment E41, further comprising an humaninterface unit comprising the filling means and being attachable to theaortic occluding balloon, said human interface optionally beingattachable in a fixed position on a patient and wherein said humaninterface is optionally integrated with the human interface defined inembodiment E26 and/or the handheld unit defined in embodiment E42,wherein said interface unit optionally can accommodate the shape of theunderlying surface of a patient or a physical surface in the vicinity ofa patient and/or can accommodate to external pressure exerted on theouter surface of a patient.

E44. The device according to embodiment E42 or 43, wherein the aorticoccluding balloon is pre-attached to the handheld unit.

E45. The device according to any one of embodiments E1-E44, where thecomputer means is configured to receive input data from theredistribution component.

E46. The device according to any one of embodiments E1-E45, furthercomprising a component attachable to the patient and being configured toadminister fluids and drugs to the patient, wherein said componentoptionally can accommodate the shape of the underlying surface of apatient or a physical surface in the vicinity of a patient and/or canaccommodate to external pressure exerted on the outer surface of apatient.

E47. The device according to embodiment E46, further compromising themeans to administer timed and controlled amount of fluids and/or drugs.

E48. The device according to any one of embodiments E1-E47, furthercomprising an additional component from the group consisting of: apatient monitor, a vitals signs monitor, a watch, an external chestcompression device, a respirator, an ECG monitor, a defibrillator, apacemaker, a pH measurement device, an ultrasound device, an ECMO/ECLSdevice, a body cooling device, an infusion pump, a capnograph, aventricular assist device, a dialysis device, touchscreen and/ortelecommunications device.

E49. The device according to any one of embodiments E1-E48, theredistribution component comprising of a component with the means fortilting the patient in a head down or head up tilt.

E50. The device according to any one of embodiments E1-E49, furthercomprising means for a self-test system, double circuitry, and usageevent data recording.

E51. The device according to any one of embodiments E1-E50, whichincludes means for detection of blood vessels and means for introductionof the redistribution component into an artery.

E52. The device according to embodiment E51, wherein the means fordetection of blood vessels comprises an ultrasound detection component,an infrared or near-infrared imaging component.

E53. The device according to embodiment E51 or E52, wherein the meansfor introduction of the redistribution component comprises 1) means formotorized movement of a percutaneous cannula or needle, 2) means formotorized introduction of the percutaneous cannula or needle into anartery, and 3) means for motorized introduction of the redistributioncomponent into an artery through or across said cannula or needle.

E54. The device according to any one of embodiments E1-E53, wherein thecomputer means communicates with at least one other therapeutic and/ormonitoring device so as to allow coordination of the operation of saidtherapeutic devices and the device according to any one of the precedingembodiments.

E55. The device according to embodiment E54, wherein the at least oneother therapeutic and/or monitoring device is selected from a cardiacresynchronization therapy device, a cardioverter-defibrillator, and acardiac pacemaker.

E56. A device according to any one of embodiments E1-E6, which isadapted to be delivered to an implanted in a human body.

E57. The device according to embodiment E56, which is configured toeffect redistribution of cardiac output in response to lowered systolicor diastolic blood pressure over a period of time of a duration thatimplies a health risk in a patient.

E58. The device according to embodiment E56 or E57, which is adapted toimplantation in the ascending aorta.

E59. The device according to any one of embodiments E56-E58, whichincludes aortic anchoring means, such as struts or an expandable frame.

E60. The device according to any one of embodiments E56-E59, whichcomprises a power source, preferably rechargeable.

E61. The device according to any one of embodiments E56-E60, wherein theredistribution component comprises an aortic expansion member as definedin any one of the preceding embodiment or comprises an aortic occlusioncomponent such as a mechanical iris or a shutter mechanism.

E62. An automated vascular catheter deployment device, which comprisesmeans for detection of blood vessels and means for introduction of acatheter into an artery.

E63. The device according to embodiment E62, wherein the means fordetection of blood vessels comprises an ultrasound detection component,an infrared or near-infrared imaging component.

E64. The device according to embodiment E62 or E63, wherein the meansfor introduction of the redistribution component comprises 1) means formotorized sideways movement of a percutaneous cannula or needle, 2)means for motorized introduction of the percutaneous cannula or needleinto an artery via longitudinal axial movement of said cannula orneedle, and 3) means for motorized introduction of the catheter into anartery through or across said cannula or needle.

E65. The device according to any one of embodiments E62-E64, wherein thecannula or needle can move sideways in a fixed or adjustable angle,preferably along a rail or cable.

E66. The device according to any one of embodiments E62-E65, which iscomprised in a housing or frame that can conform to the shape of theupper part of a patient frontal part of the thigh.

E67. A method for providing resuscitation or suspended state in a humancardiac arrest patient, said method comprising subjecting the patient toheart massage (chest compression) while at the same time ensuringredistribution of the cardiac output to preferentially supply blood tothe brain and the heart.

E68. The method according to embodiment E67, wherein said redistributionis accomplished by at least one of the following:

-   -   occlusion of the aorta caudal to the left subclavian artery;    -   head-down or head-up tilting of the patient so as to reach an        angle of between 30 and 90 degrees relative to the horizontal        plane;    -   applying an external compression force onto the abdomen and/or        thigh(s) and/or arm(s) so as to reduce the perfusion distal to        the external compression force;    -   passively raising the legs to reach an angle between 30 and 90        degrees relative to the horizontal plane.

E69. The method according to embodiment E67 or E68, wherein said chestcompression is manual or accomplished by use of a mechanical chestcompression device.

E70. The method according to any one of embodiments E67-E69, wherein atleast one of the following treatments is/are also provided to thepatient:

-   -   administration of fluids, including saline and buffers such as        bicarbonate,    -   administration of vasopressive drugs, including vasopressin and        analogues,    -   administration of a tissue-protecting agent, such as        erythropoietin;    -   administration of anti-arrhythmic drug, such as amiodarone;    -   reduction of body temperature, such as by use of cold IV-fluid        infusion, cooling catheters, transnasal evaporative cooling,        extracorporeal cooling or total liquid ventilation with        temperature controlled perfluorocarbons.

E71. The method according to embodiment E70, wherein the treatments areprovided repeatedly, optionally according to a fixed sequence.

E72. The method according to any one of embodiments E67-E71, whichcomprises that redistribution is accomplished by occlusion of the aortacaudal to the left subclavian artery.

E73. The method according to embodiment E72, wherein occlusion isaccomplished by introducing a device according to any one of embodimentsE1-E46 into the aorta, preferably via the femoral artery, andsubsequently decreasing or interrupting the blood flow distal to theredistribution component by expanding the redistribution component ofsaid device.

E74. The method according to embodiment E73, wherein the redistributioncomponent is expanded in a controlled manner in response tomeasurement(s) that indicate the degree of occlusion and correctplacement of said device in the patient's aorta.

E75. The method according to embodiment E74, wherein said measurement(s)is/are selected from the group consisting of:

-   -   duration of expansion redistribution component usage;    -   blood flow passing by the redistribution component;    -   blood pressure distal of the redistribution component,        optionally combined with blood pressure proximal to the        redistribution component;    -   aortic O₂ saturation distal of, and preferably in close        proximity to, the redistribution component, optionally combined        with arterial O₂ saturation proximal of the redistribution        component.

E76. The method according to any one of embodiments E73-E75, whereinexpansion of the redistribution component is controlled manually or bythe computer means of said device to avoid incorrect positioning orexpansion degree of said device and by activating the failsafe ofembodiment E9 in case said device is verified to be incorrectlypositioned thereby interrupting the expansion of the redistributioncomponent to allow subsequent correct positioning.

E77. The method according to any one of embodiments E67-E76, wherein theredistribution is temporarily interrupted at regular or irregularintervals so as to ensure sufficient perfusion of all parts of the bodyof the patient.

E78. The method according to any one of embodiments E67-E77, which actsduring or as a bridge to one or more of

-   -   therapeutic hypothermia; angioplasty, including PCI and        angiography; dialysis; administration of drugs such as        vasopressors, thrombolytic drugs such as fibrinolytics, fluids,        bicarbonate, antidotes, and antiarrhythmic drugs; the use of        ultrasound, X-ray, CT, or MR; intubation; mechanical        ventilation; ventricular assist devices; heart transplantation,        including artificial heart transplantation; surgery, including        CABG surgery and valve surgery; blood transfusion; placement of        external or internal pacemaker or ICD; catheter ablation;        thromboendarterectomy; defibrillation; transportation; ECMO;        ECLS and cardiopulmonary bypass.

E79. The method according to any one of embodiments E67-E78, furthercomprising lowering the restriction on perfusion delivered to the brainand heart through the use of a vasodilator, hereunder specificallysodium nitroprusside or nitroglycerin and repeated administration ofsodium nitroprusside or nitroglycerin, hereunder repetition in intervalsof 2-10 minutes.

E80. The method according to embodiment E79, further comprising the useof an aortic expansion member to prevent the systemic vascular collapsecaused by the vasodilator.

E81. The method according to any one of embodiments E47-E60, furthercomprising the use of any one of the following: activecompression-decompression CPR, impedance threshold device, adenosineadministration, controlled pauses in the CPR (e.g. compressions for 20seconds, then a pause in compressions for 20 seconds.)

E82. A method for providing resuscitation or suspended state throughredistribution of cardiac output to increase supply to the brain andheart for a human in cardiac arrest or imminent cardiac arrest, themethod comprising subjecting the patient to external chest compressionwhile at the same time ensuring redistribution of the cardiac outputaccomplished by occlusion of the aorta caudal to the left subclavianartery, and comprising lowering the restriction on perfusion deliveredto the brain and heart through the use of a vasodilator, hereunderspecifically sodium nitroprusside or nitroglycerin, hereunder repetitionin intervals of 2-10 minutes.

E83. A method according to embodiment E82, further acting as a bridge toone or more of the following:

-   -   ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI        and angiography; dialysis; therapeutic hypothermia, hereunder        cold IV-fluid infusion, cooling catheters, transnasal        evaporative cooling, extracorporeal cooling or total liquid        ventilation;

administration of drugs, hereunder vasopressors or vasodilators,hereunder sodium nitroprusside or nitroglycerin, thrombolytic drugs suchas fibrinolytics, fluids, bicarbonate, antidotes, tissue-protectingagents and antiarrhythmic drugs, such as amiodarone; the use ofultrasound, X-ray, CT, or MR; intubation; mechanical ventilation;ventricular assist devices; surgery, including CABG surgery and valvesurgery; blood transfusion; placement of external or internal pacemakeror ICD; catheter ablation; thromboendarterectomy; heart transplantation;defibrillation; transportation.

E84. A method for providing resuscitation or suspended state throughredistribution of cardiac output to increase supply to the brain andheart for a human in cardiac arrest or imminent cardiac arrest, themethod comprising subjecting the patient to external chest compressionwhile at the same time ensuring redistribution of the cardiac outputaccomplished by sustained abdominal compression or abdominal binding,and comprising lowering the restriction on perfusion delivered to thebrain and heart through the use of a vasodilator, hereunder specificallysodium nitroprusside or nitroglycerin, hereunder repetition in intervalsof 2-10 minutes, and comprising acting as a bridge to one or more of thefollowing:

-   -   ECMO; ECLS; cardiopulmonary bypass; angioplasty, including PCI        and angiography; dialysis; therapeutic hypothermia, hereunder        cold IV-fluid infusion, cooling catheters, transnasal        evaporative cooling, extracorporeal cooling or total liquid        ventilation;

administration of drugs, hereunder vasopressors or vasodilators,hereunder sodium nitroprusside or nitroglycerin, thrombolytic drugs suchas fibrinolytics, fluids, bicarbonate, antidotes, tissue-protectingagents and antiarrhythmic drugs, such as amiodarone; the use ofultrasound, X-ray, CT, or MR; intubation; mechanical ventilation;ventricular assist devices; surgery, including CABG surgery and valvesurgery; blood transfusion; placement of external or internal pacemakeror ICD; catheter ablation; thromboendarterectomy; heart transplantation;defibrillation; transportation.

E85. A method for stopping or reducing bleeding from tissue(s) ororgan(s), hereunder during e.g. surgery or other situations wherebleeding occur of said tissue(s) or organ(s), the method comprisinginserting an occlusion device into a blood vessel, which supplies saidtissue(s) or organ(s) with blood, wherein said occlusion device isreversibly expanded to occlude said blood vessel and wherein thepressure exerted by the expanded occlusion device on the wall of theblood vessel is adapted to be between 1 and 2 times the vascularpressure difference across the occlusion device.

E86. The method according to embodiment E85, wherein the pressureexerted by the expanded occlusion device on the wall of the blood vesselis adapted to be at most 1.9 times the vascular pressure differenceacross the occlusion device, such as at most 1.8, at most 1.7, at most1.6, at most 1.5, at most 1.4, at most 1.3, at most 1.2 and at most 1.1times.

E87. The method according to embodiment E85 or E86, wherein theocclusion device includes or is attached to at least one vascularpressure sensor, which can determine the vascular pressure in said bloodvessel.

E88. The method according to embodiment E87, wherein the at least onepressure sensor is positioned in said vessel between the occlusion insaid vessel and said tissue(s) or organ(s) and/or is positioned in thepart of said vessel which is separated from said tissue(s) or organ(s)by the occlusion.

E89. The method according to any one of embodiments E85-E88, wherein theocclusion device is part of a device as embodimented in any one ofembodiments E1-E66, where said occlusion device is identical to theaortic expansion member of embodiment E6 or may be a modified version ofsaid aortic expansion member, which is adapted be able to fit into otherblood vessels.

1. A device for providing resuscitation or suspended state throughredistribution of cardiac output to increase supply to the brain andheart for a patient, the device comprising an electrically or manuallycontrollable redistribution component in the form of a catheterconfigured to be attachable to the patient and to interact with thepatient to provide redistribution of the cardiac output to increasesupply to the brain and heart, the redistribution component following apredefined reaction pattern based on an electrical signal, computerconfigured to 1) receive a patient data which identifies physiologicaland/or anatomical characteristics of the patient; and 2) provide theelectrical signal for controlling the redistribution component and/orfor presenting the physiological and/or anatomical characteristics for auser based on the patient data or a standard response, and a componentconfigured for detection of blood vessels and a motorized componentconfigured for introduction of the catheter into an artery.
 2. Thedevice according to claim 1, wherein the component configured fordetection of blood vessels comprises an ultrasound detection component,or an infrared or near-infrared imaging component.
 3. The deviceaccording to claim 1, wherein the component configured for introductionof the redistribution component comprises 1) a component configured formotorized sideways movement of a percutaneous cannula or needle, 2) acomponent configured for motorized introduction of the percutaneouscannula or needle into an artery via longitudinal axial movement of saidcannula or needle, and 3) a component configured for motorizedintroduction of the catheter into an artery through or across saidcannula or needle.
 4. The device according to claim 1, wherein thecannula or needle can move sideways in a fixed or adjustable angle,preferably along a rail or cable.
 5. The device according to claim 1,which is comprised in a housing or frame configured to be applied to aposition on a human limb selected from one, two or all members of thegroup consisting of the frontal part of the thigh, the frontal part ofthe pelvis, and the frontal part of the groin, and which is preferablyconfigured so that the housing or frame can conform to the shape of theupper part of a patient frontal part of the thigh.
 6. The deviceaccording to claim 1, where the redistribution component comprises anelongated body extending between a proximal end and a distal end, thedistal end being insertable into the patient, where the redistributioncomponent comprises an aortic expansion member and inflation componentconnected to the aortic expansion member for expanding the aorticexpansion member.
 7. The device according to claim 6, further comprisingan adaptable tissue protection mechanism configured to: determine ablood pressure or blood flow present in a blood vessel of the patientduring cardiac compression; determine an aortic expansion membercharacteristics defining a degree of expansion of the aortic expansionmember based on the determined blood pressure or blood flow; and toprovide an electrical signal for controlling the inflation componentconfigured in accordance with the determined aortic expansion membercharacteristics.
 8. The device according to claim 7, further comprisinga location safety mechanism comprising at least one first sensor capableof determining a biosignal which is characteristic for aorta of thepatient and an electronic circuit configured to verify a position of theexpansion member in aorta based on the biosignal.
 9. The deviceaccording to claim 8, where the at least one first sensor comprises apressure sensor.
 10. The device according to claim 8, where the firstsensor is located on the redistribution component to determine thebiosignal in a position distal to the aortic expansion member.
 11. Thedevice according to claim 10, where the device is configured to use datafrom the first sensor in combination with data from sensors located atother locations.
 12. The device according to claim 11, where at leastone of the other sensors is located on the redistribution component todetermine the biosignal in a position proximal to the aortic expansionmember.
 13. The device according to claim 8, where the location safetymechanism is configured to determine whether the aortic expansion memberis located in a position selected from a group consisting of: apulsating vessel in accordance with being the aorta of the patient, apulsating vessel not in accordance with being the aorta, a pulsatingvessel being indeterminate as the aorta of the patient, a venous vessel,a tissue compartment not being a blood vessel and a tissue compartmentindeterminate in location.
 14. The device according to claim 8, furthercomprising a second sensor inside the aortic expansion member orproximal to the expansion member.
 15. The device according to claim 8,wherein the device is configured with a feedback loop receiving datafrom at least one of the first and second sensor, to control the fillingof the aortic expansion member.
 16. The device according to claim 6,further comprising at least one sensor for determining pressure, flow,O₂ saturation or concentration, and/or volume data significant forpressure, flow and/or volume of a fluid inside the aortic expansionmember or inside a blood vessel or tissue of the patient.
 17. The deviceaccording to claim 16, where the computer is configured to compare thepressure, flow and/or volume data with reference input data and based onthe comparison to verify a position of the aortic expansion member inthe body.
 18. The device according to claim 16, where the computer isconfigured to determine the size and type of blood vessel by analyzingthe pressure flow and/or volume data continuously.
 19. The deviceaccording to claim 6, which further comprises at least one transponderand transceiver system for location verification of the redistributioncomponent and/or of the aortic expansion member.
 20. The deviceaccording to claim 6, which further comprises at least one transponderand transceiver system for determination of the position of the outerboundary of the aortic expansion member.
 21. The device according toclaim 19, wherein at least one transponder is positioned in the part ofthe device intended to be introduced into a patient.
 22. The deviceaccording to claim 19, wherein at least one transceiver is positioned inthe part of the device intended to be introduced into a patient.
 23. Thedevice according to claim 19, where at least one transponder or at leastone transceiver is adapted to be positioned on the external surface of apatient in a non-invasive manner.
 24. The device according to claim 1,wherein the redistribution component comprises 1) an elongated bodyextending between a proximal end and a distal end, the distal end beinginsertable into the patient, and 2) an aortic expansion member andinflation component connected to the aortic expansion member forexpanding the aortic expansion member, said device comprises a locationsafety mechanism comprising at least one first sensor capable ofdetermining pressure distal to the aortic expansion member, where thepressure is characteristic for aorta of the patient, and an electroniccircuit configured to verify a position of said expansion member inaorta based on said pressure, said device optionally comprises at leastone second sensor of pressure inside the aortic expansion member orproximal to the expansion member, and said device is configured with afeedback loop receiving pressure data from at least one of said firstsensor and optional second sensor to control the filling of the aorticexpansion member so as to control the pressure of the aortic expansionmember.
 25. (canceled)
 26. (canceled)
 27. (canceled)
 28. (canceled) 29.(canceled)
 30. (canceled)